Chronic Hypertension and Pregnancy (CHAP) Project | NCT02299414

ID	Type	Description	Link
U01HL119242-01	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
Columbia University	OTHER
Drexel University College of Medicine	OTHER
Rutgers, The State University of New Jersey	OTHER
Lehigh Valley Hospital

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti-hypertensive therapy to goal <140/90 mmHg	Experimental	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used	Drug: Anti-hypertensive therapy
No anti-hypertensive unless BP is severe (≥160/105 mmHg	Active Comparator	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used	Other: No anti-hypertensive therapy (unless BP is severe)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-hypertensive therapy	Drug	1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Adverse Perinatal Outcome	One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB <35 weeks (not due to spontaneous preterm labor or membrane rupture).	Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death
Small for Gestational Age (Safety)	Birth weight less than 10th percentile for gestational age at birth according to accepted national standard	Until delivery

Secondary Outcomes

Measure	Description	Time Frame
Composite of Maternal Death or Severe Cardiovascular Morbidity	One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure	Up to 6 weeks (4-12 weeks) after delivery
Severe Maternal Hypertension + Components of the Primary Composite Endpoint

Other Outcomes

Measure	Description	Time Frame
Superimposed Preeclampsia	Mild or severe, including eclampsia	Up to 2 weeks after delivery
Superimposed Gestational Hypertension	Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure <140/90);
Singleton; and
viable pregnancy <23 weeks of gestation.

Exclusion Criteria:

Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment);
Severe hypertension including patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension);
Multi-fetal pregnancy;
Known secondary cause of chronic hypertension;
High-risk co-morbidities for which treatment may be indicated:
- Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years
- Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant)
- Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria*) or creatinine >1.2.
  
  *If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg.
- Cardiac disorders: cardiomyopathy, angina, CAD
- Prior stroke
- Retinopathy
- Sickle cell disease
Known major fetal anomaly;
Known fetal demise;
Suspected IUGR;
Membrane rupture or planned termination prior to randomization;
Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial;
Contraindication to labetalol and nifedipine (e.g. know hypersensitivity);
Current substance abuse or addiction (cocaine, methamphetamine)
Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee)
Physician or provider refusal
Patient refusal *The minimum age varies by center

Name	Affiliation	Role
Alan Tita, MD, PhD	University of Alabama at Birmingham - Clinical Coordinating Center	Principal Investigator
Gary Cutter, PhD	University of Alabama at Birmingham-Data Coordinating Center	Principal Investigator
Jeff Szychowski, PhD	University of Alabama at Birmingham-Data Coordinating Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham, Clinical Coordinating Center		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38949541	Derived	Sanusi AA, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Kuo HC, Sinkey RG, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Eugene Chang, Osmundson S, Quinones J, Szychowski JM, Tita ATN. Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension. Obstet Gynecol. 2024 Jul 1;144(1):126-134. doi: 10.1097/AOG.0000000000005613. Epub 2024 May 23.
38781591

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 13, 2021

Arm/Group Information

ID	Title	Description
BG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
BG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Composite Primary Outcome

Title	Measurements
	OG000353 OG001427

Preeclampsia with Severe Features

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		<0.001		Risk Ratio (RR)	.82			2-Sided	95	.73	.92					Superiority
OG000 OG001

Primary

Small for Gestational Age (Safety)

Birth weight less than 10th percentile for gestational age at birth according to accepted national standard

Analysis is restricted to 2270 (1146 in the Treatment Group and 1124 in the Standard Group) who were delivered and who had complete assessments during delivery.

Posted

Count of Participants

Participants

Until delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Secondary

Composite of Maternal Death or Severe Cardiovascular Morbidity

One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure

Posted

Count of Participants

Participants

Up to 6 weeks (4-12 weeks) after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Secondary

Severe Maternal Hypertension + Components of the Primary Composite Endpoint

Persistent severe hypertension with or without proteinuria + the primary composite

Posted

Count of Participants

Participants

Up to 2 weeks postpartum or 90 days for neonatal death

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Secondary

Preterm Birth and Indicated Preterm Birth (<37 Weeks)

Preterm birth and Indicated preterm birth (<37 weeks) includes any preterm birth less than 37 weeks

Posted

Count of Participants

Participants

Until delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Secondary

Composite of Severe Neonatal Morbidities

One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV

Posted

Count of Participants

Participants

Up to 90 days post delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Secondary

Adherence to Treatment After Delivery

Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications.

Analysis is restricted to 706 in Treatment Group and 479 in Standard Group who had complete antihypertensive therapy assessments at the follow-up study visit.

Posted

Count of Participants

Participants

6 weeks (4-12 weeks) after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Superimposed Preeclampsia

Mild or severe, including eclampsia

Posted

Count of Participants

Participants

Up to 2 weeks after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Superimposed Gestational Hypertension

Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation

Posted

Count of Participants

Participants

Enrollment (between 6 and 18 weeks gestation) to delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Severe Hypertension

Blood pressure ≥160/110

Posted

Count of Participants

Participants

Up to 6 weeks (4-12 weeks) after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Cesarean Delivery

Cesarean delivery

Posted

Count of Participants

Participants

Until delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Units

Other Pre-specified

Blood Transfusion

During pregnancy or postpartum

Posted

Count of Participants

Participants

Up to 6 weeks

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Units

Other Pre-specified

NICU Admission

Any NICU admission

Posted

Count of Participants

Participants

Up to 6 weeks (4-12 weeks) after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Low Birth Weight

Birth weight <2500g

Posted

Count of Participants

Participants

At birth

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Units	Counts

Other Pre-specified

Ponderal Index

Mean ponderal index, mass/height^3 at birth

data incomplete for 71 in the Treated Group and 83 in the Standard Group

Posted

Mean

Standard Deviation

g/cm^3

At birth

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Head Circumference

Mean head circumference

data incomplete for 84 in the Treated Group and 97 in the Standard Group

Posted

Mean

Standard Deviation

At birth

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Placental Weight

Mean placental weight

data incomplete for 549 in the Treated Group and 562 in the Standard Group

Posted

Mean

Standard Deviation

At delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Hypoglycemia

Prevalence of hypoglycemia

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Bradycardia

Prevalence of bradycardia

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Hypotension

Incidence (%) with hypotension

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Respiratory Distress Syndrome (RDS)

Incidence (%) with respiratory distress syndrome (RDS)

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Bronchopulmonary Dysplasia (BPD)

Incidence (%) with bronchopulmonary dysplasia (BPD)

Posted

Count of Participants

Participants

Up to 3 months after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Intubation/Ventilation

Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Intraventricular Hemorrhage (IVH)

Incidence (%) with any IVH and with IVH Grades III and IV

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Necrotizing Enterocolitis (NEC)

Incidence (%) with necrotizing enterocolitis (NEC)

Posted

Count of Participants

Participants

Up to 3 months after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Hyperbilirubinemia

Incidence (%) with hyperbilirubinemia

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

5-min Apgar Score

Incidence (%) with Apgar score <7 (range 0-10 with lower scores indicating worse outcome)

Posted

Count of Participants

Participants

At delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Sepsis

Incidence (%) with proven sepsis

Posted

Count of Participants

Participants

From delivery to hospital discharge (2 - 3 days after delivery)

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Unscheduled Prenatal Clinic or ER Visits

Number of unscheduled clinic or ER visits before and after delivery

Posted

Mean

Standard Deviation

number of encounters

Up to 3 months after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Hospitalizations

Number of hospitalizations before or after delivery

Posted

Mean

Standard Deviation

number of encounters

Up to 3 months postpartum

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Postpartum Unscheduled or ER Visits

Number of postpartum unscheduled or ER visits

Posted

Mean

Standard Deviation

number of encounters

Up to 3 months after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Postpartum Hospitalizations

Number of postpartum hospitalizations

Posted

Mean

Standard Deviation

number of encounters

Up to 3 months after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Other Pre-specified

Neonatal Hospital Stay of 3 or More Days

Frequency of neonatal hospital stays lasting at least 3 days

Posted

Count of Participants

Participants

after delivery

ID	Title	Description
OG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Anti-hypertensive Therapy to Goal <140/90 mmHg	Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	42	1,208	113	1,208	0	1,208
EG001	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg	Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.	52	1,200	126	1,200	0	1,200

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,208 at risk EG0010 events0 affected1,200 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Foetal anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Foetal Death	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG00036 events36 affected1,208 at risk EG00142 events42 affected1,200 at risk
Foetal Growth Restriction	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,208 at risk EG0010 events0 affected1,200 at risk
Preeclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG00010 events10 affected1,208 at risk EG00124 events24 affected1,200 at risk
Death Neonatal	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected1,208 at risk EG0018 events8 affected1,200 at risk
Stillbirth	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG00013 events13 affected1,208 at risk EG00119 events19 affected1,200 at risk
Maternal Death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0012 events2 affected1,200 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Congenital Pneumonia	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,208 at risk EG0010 events0 affected1,200 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Gestational Hypertension	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0010 events0 affected1,200 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,208 at risk EG0013 events3 affected1,200 at risk
Pulmonary Oedema	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,208 at risk EG0015 events5 affected1,200 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Wound Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0014 events4 affected1,200 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Gravitational Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
HELLP Syndrome	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Hyperbilirubinaemia Neonatal	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,208 at risk EG0010 events0 affected1,200 at risk
Premature Rupture of Membranes	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0012 events2 affected1,200 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Bronchopulmonary Dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Chest Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0010 events0 affected1,200 at risk
Cleft Lip and Palate	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Congenital Genitourinary Abnormality	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Congenital Diaphragmatic Hernia	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Diaphragmatic Aplasia	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Ganglioneuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Holoprosencephaly	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Hypoxic-ischaemic Encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Neonatal Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Neonatal Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0010 events0 affected1,200 at risk
Oesophageal Operation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Oligohydramnios	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0012 events2 affected1,200 at risk
Palpitations	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Patent Ductus Arteriosus	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Placenta Accreta	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected1,208 at risk EG0010 events0 affected1,200 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Postpartum Haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Preterm Premature Rupture of Membranes	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0012 events2 affected1,200 at risk
Shoulder Dystocia	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Trisomy 21	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0013 events3 affected1,200 at risk
Ventricular Septal Defect	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Trisomy 18	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Pyloric Stenosis	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Multiple Cardiac Defects	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0014 events4 affected1,200 at risk
Renal Aplasia	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Talipes	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected1,208 at risk EG0011 events1 affected1,200 at risk
Microcephaly	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Dandy-Walker syndrome	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Hypoplastic Left Heart Syndrome	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Kidney Malformation	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Atrial Septal Defect	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Anomalous Pulmonary Venous Connection	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Chondrodystrophy	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Subarachnoid Haemorrhage Neonatal	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Shortened Cervix	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0010 events0 affected1,200 at risk
Renal Tubular Necrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Seizure	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Purulent Discharge	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Foetal Chromosome Abnormality	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Appendicitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Uterine rupture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Blood pressure abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0012 events2 affected1,200 at risk
Eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Fetal growth restriction	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Gestational diabetes	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Hypothermia neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Neonatal disorder	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0012 events2 affected1,200 at risk
Poor weight gain neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0011 events1 affected1,200 at risk
Premature baby	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0012 events2 affected1,200 at risk
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected1,208 at risk EG0010 events0 affected1,200 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Neonatal respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0012 events2 affected1,200 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected1,208 at risk EG0011 events1 affected1,200 at risk
Abdominal operation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected1,208 at risk EG0010 events0 affected1,200 at risk
General Event	General disorders	MedDRA (10.0)	Systematic Assessment	EG00012 events12 affected1,208 at risk EG00117 events17 affected1,200 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D012457	Salicylamides
D000577	Amides
D000588	Amines
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds